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The USFDA Launches Initiative to Reduce Infusion Pump Safety Risks

The U.S. Food and Drug Administration has announced a new initiative to address what FDA’s Center for Devices and Radiological Health (CDRH) has referred to as “rampant” safety issues associated with the technology utilized by external infusion pumps. CDRH Director Jeffrey Shuren has called this a first for the agency, exercising its authority over an entire class of devices. The initiative involves launching a proactive model of industry involvement which seeks to set and publically define the bar for the design, manufacture and control of infusion pumps.

Infusion pumps are widely used in hospitals, other clinical settings, and the home. The devices are intended to allow a greater level of control, accuracy, and precision in drug delivery, and help to reduce medication errors.

Shuren continued by stating that, “these pumps often provide critical fluids to high-risk patients, so failures have significant implications. It is time for a more comprehensive approach than we’ve taken to date.”

FDA reports that up until this point in time, their practice has been to deal with pump issues on a case by case basis, but sobering figures between 2004 and 2009 have prompted the agency to alter their practice. These figures include;

· 87 safety based recalls

· 56,000 reportable adverse events

· More than 500 patient deaths

The Initiative White Paper issued by FDA describes the broad based actions that FDA intends to take in order to offer increased patient protection, including;

1. The establishment of additional and specific requirements for pump manufacturers

2. The proactive facilitation of device improvements

3. The advancement of user awareness

This comprehensive and ground breaking initiative will include, but may not be limited to the following;

· An initiative white paper

· A letter to pump manufacturers

· A new and exceedingly specific guidance document

· Updated inspection manuals

· A pump specific web site and

· A public meeting to be held in May 2010

Reported problems have most commonly been related to:

software defects, including failures of built-in safety alarms

user interface issues, such as ambiguous on-screen instructions that lead to dosing and user errors; and

mechanical or electrical failures, including components that break under routine use, premature battery failures, and sparks or pump fires

incomplete MDRs

an inability to indentify exactly how many pump units were actually in use, which leads to an inability precise rates of adverse effects

Failures of infusion pumps have been observed across multiple manufacturers and pump types. The FDA says that many of the reported problems appear to be related to deficiencies in device design, engineering, validation and usability.

Draft Guidance Document;

As part of its initiative, FDA is moving to establish additional premarket requirements for infusion pumps, in part through issuance of a new draft guidance for infusion pump manufacturing and control. The guidance also requires that infusion pump manufacturers provide additional design and engineering information to the agency during premarket review of the devices.

Among other things, the new guidance instructs manufacturers to;

· Include in their 510(k) applications and explanation of the steps they have taken to reduce the risk of their devices at each stage of the life cycle, from design to actual operation

· Test pumps in the environment of routine use, which includes including clinical environments in validation testing, defining the worst case scenario as those that include real-life use conditions, including inexperienced users

· Be prepared for the agency to withhold 510(k) approvals until manufacturing facilities specific to each pump have been inspected

Letter to Manufacturers;

The FDA also issued a letter to infusion pump manufacturers, informing them that they may need to conduct additional risk assessments to support clearance of new or modified pumps.

In addition to alerting manufacturing of this intended change, the letter offers manufacturers the option of submitting their infusion pump software codes to experts at the FDA for static analysis prior to premarket review. Static analysis is a diagnostic technique that can help detect software problems early in the device development process. The agency previously invited manufacturers to make use of an open-source software safety model developed through the Generic Infusion Pump project, an ongoing collaboration with outside researchers aimed at improving pump design.

Public Meeting;

FDA is also hosting public meeting on infusion pump design, and launching a new Web page devoted to infusion pump safety.

The FDA’s public workshop will be held May 25-26, 2010. Participants will discuss observed safety problems, and explore opportunities to work with others, including foreign regulators, to improve the design of infusion pumps on the market or in development, in order to reduce pump malfunctions and errors.

“Working with industry and users, we can help develop safer, more effective infusion pumps and improve patient care” said Shuren.

The public meeting is limited to 300 attendees, but may be viewed online (see reference section) for up to 30 days after video posting. The meeting is expected to include at least some contention from manufacturers, as public from manufacturers were quickly issued.

Pump Web Site;

The agency’s new infusion pump safety Web page features basic information about infusion pumps and steps that patients and healthcare professionals can take to prevent and report safety problems, even before new or redesigned pumps are brought to the market.

Advice to Clinicians;

To help reduce infusion pump risks, the FDA asks clinicians to consider the following general strategies.

Plan ahead and be ready to respond in the event of a pump failure

Label infusion pump channels and tubing to prevent errors

Check infusion pump settings and monitor patients for signs of over- or under-infusion